The Ruling on the Affordable Care Act Next Week

The healthcare industry is abuzz this week with the Supreme Court set to meet next week on the constitutionality of the Affordable Care Act. All over the internet, opinions and stories are bursting about why or why not they should find the law to be constitutional or unconstitutional.

Ruth Marcus of the Washington Post believes that the $116 billion spent by the US Government is all that needs to be said about why everyone should be mandated to have healthcare.

Vermont Public Radio profiles two hospitals in Miami - one private hospital and one public who has taken hits for those who are not insured in their area.  They look forward to the new ruling as a way to better staff their hospital and provide more care.

Bloomberg Business Week takes and in depth look on how the preceedings with the Supreme Court will go from who will be in the court room to hear the arguments to what will be discussed.

According to The Global Post, only 20% of Americans think the law is constitutional.

How do you think the Supreme Court will rule?

There is a lot of work to be done as the ACA implementation begins and there is no better time or place than the Medicaid Managed Care Congress to meet with Federal and State Government Officials, Health Plan Leaders and Innovative Solution Providers to move into the era of reform implementation and Medicaid Modernization.  Join us at the Medicaid Manged Care Congress April 30-May 2, 2012, in Baltimore, Maryland to discuss the latest news and prepare for the changes in Medicaid.  As a reader of this blog, when you register and mention code XP1726BLOG, you'll receive a discount of 25% off the standard rate.

Medicaid Managed Care Congress Session Spotlight: Medicaid and Health Insurance Exchange Integration

There are a lot of people who are right on the border of qualifying for Medicaid, and there are a lot of questions about how they will manage people who may "churn" between Medicaid and Exchanges. For example, what if some weeks you work overtime and dont qualify for Medicaid and sometimes you don't work overtime and are eligible for Medicaid? They need to figure out a way to ensure continuous care--ideally, people could keep their same doctors so the care is continuous if they churn between medicaid and healthcare purchased through exchanges.  Also, some states are looking to have Medicaid offered through the same channel as Exchanges. I dont know if everyone is doing it, but ideally you would plug in your personal information and if you're eligible for Medicaid you could enroll in it through there.

The Medicaid Managed Care Congress' Panel Discussion Medicaid and Health Insurance Exchange Integration with a moderator from United Healthcare and representatives from Massachusetts, Michigan and Rhode Island will address these factors and more.  For more on the Medicaid Manged Care Congress taking place April 30-May 2, 2012, in Baltimore, Maryland, download the brochure.  As a reader of this blog, when you register and mention code XP1726BLOG, you'll receive 25% off the standard rate!

 John Kaelin, SVP,
Health Reform,
UnitedHealth  

Featured Session: Medicaid and Health Insurance Exchange Integration
Featured Participants:

• - Moderator: John Kaelin, Senior Vice President, Health Reform, UnitedHealth Group
• - Julian J. Harris, MD, MBA, MSc, Medicaid Director, Executive Office of Health and Human Services, Massachusetts
• - Amy Allen, Healthcare Reform Planning Director, Department of Community Health, Michigan
• - Deborah Florio, Administrator, Center for Child & Family Health,Rhode Island Department of Human Services

About the session: Health Insurance Exchanges are a huge part of the ACA, and Medicaid’s integration with them varies by states. With a fast approaching 2013 deadline, states are scrambling to create regulations and guidance for plans. With approximately 80% of Exchange participants expecting to receive some sort of subsidy, Medicaid plans need to know how Exchanges will affect their current offerings. In this session, you’ll learn from states that are in various stages of creating Exchanges.

• • Compare and contrast Medicaid enrollees and potential Exchange enrollees
• • Identify how your plan will need to change to better serve additional members

Meg Murray on if there are specific areas where health plans need to expand their networks?

Recently, Meg Murray,CEO, Association for Community, Affiliated Health Plans, sat down with Medicaid Managed Care Congress director Sarah Gordon to discuss some of the biggest topics in the industry. 

Today, we feature Meg's answer to this question:

In general, are there specific areas where health plans need to expand their networks?

Her response:

We continue to hear about problems with the pediatric specialists. Dermatology is also one we often hear about. Of course the dental issues. I think everyone is very aware of the dental. As we move into the expansion population, a lot of this population coming on board are going to be people with significant mental health and substance abuse problems. That has continued to be a current concern of getting enough providers with those specialties. So, our plans are now actively looking at how they can enhance the network for adults, one. And then also for people with mental health issues.

Download the full interview at the MMCC Resource page.  Meg will be the moderator for the Health Plan CEO Panel: Ensure Member Access through Robust Provider Networks at this year's Medicaid Managed Care Congress taking place April 30-May 2.  For more information on the event, download the brochure.  If you'd like to attend, mention code XP1726BLOG when you register to save 25% off the standard rate!

How to Maintain Strong Medicaid Provider Networks to Prepare for 2014

Healthcare reform will have a dramatic impact on Medicaid eligibility by including adults at or below 133% FPL. Now is the time for Managed Care plans to evaluate their current networks to ensure they’re ready for the influx of new members in 2014. Not only will there be more lives to cover, it’s likely that the population will differ from the traditional Medicaid member, with more single young adults and more men.

The Health Plan CEO Panel at the 20th Annual Medicaid Managed Care Congress will discuss how you can provide high quality care to new members through robust provider networks. Join our distinguished CEO speakers Paul Rothman, President, Prestige Health Choice; Jay Feldstein, MD, Regional President, AmeriHealth Mercy; Al King , CEO, Amerigroup Tennessee; and Meg Murray , CEO, ACAP, who will share their strategies to maintain and expand networks amidst state rate cuts by identifying network gaps and leveraging technology to expand network coverage.

Find out more about session and the rest of the program by downloading the brochure.

For a preview the event, download the exclusive podcast “Ensure Member Access through Robust Provider Networks” featuring ACAP’s CEO, Meg Murray discussing network expansion. Download the podcast here.

The Medicaid Managed Care Congress is taking place April 30-May 2, 2012. As a reader of this blog, you can use priority code XP1726BLOG to receive 25% off of the standard rate! If you have any questions or need any further information, feel free to email jpereira@iirusa.com.

Who can you meet at the GP Summit this month?

In just two weeks the Government Programs Summit will bring together hundreds of drug pricing and compliance executives from dozens of pharmaceutical and generic companies eager to get the most comprehensive, up to date information on the reimbursement programs affecting your business.

Here's who has registered to join us:

340B Prime Vendor Program/Apexus * Acorda Therapeutics * Afaxys Inc * Akin Gump Strauss Hauer & Feld * Akrimax Pharmaceuticals LLC * Allergan Inc * Alliance Life Science Consulting Group * Alvogen Inc * American Pharmaceutical Association * Amneal Pharmaceuticals * Amylin Pharmaceuticals Inc * Apexus * APP Pharmaceuticals * Aptalis Pharma * Aurobindo Pharma USA * Azur Pharma * Banner Pharmacaps Inc * Baxter International Inc * Bayer HealthCare * Bristol Myers Squibb Company * Brookings Institution * Cangene BioPharma * Celgene * Centers for Medicare & Medicaid Services * Cephalon Inc * CIS * CMS * Compliance Implementation Services * Cornerstone Biopharma Inc * Daiichi Sankyo * daVIZta Incorporated * Department of Health & Human Services * Dey Pharma LP * EDS * Eisai Inc * Eli Lilly & Company * Endo Pharmaceuticals * Ernst & Young * Forest Laboratories * Fresenius Medical Care * Galderma Laboratories * Gilead Sciences Inc * Government Pricing Specialists * HighPoint Solutions * Hospira Worldwide Inc * HP Enterprise Services * HP NC Medicaid * HRSA Office of Pharmacy Affairs * Huron Life Sciences * Impax Laboratories * Janssen * Jazz Pharmaceuticals Inc * JHP Pharmaceuticals LLC * Johnson & Johnson * Kadmon Pharmaceuticals * LEO Pharma Inc * Loma Linda Univ Med Ctr * McKesson Packaging Services * Medicis Pharmaceutical * MLEE Consulting * Model N * Mylan Pharmaceuticals Inc * National Association of Chain Drug Stores * Navigant Consulting * Nephron Pharmaceuticals Corporation * Novartis Pharmaceuticals Corporation * Office of Pharmacy Affairs HRSA * Optimer Pharmaceuticals * Perrigo Pharmaceuticals * Pfizer * Procter & Gamble * Purdue Pharma * Revitas * Sanofi Aventis * Shire Pharmaceuticals * Sigmapharm Laboratories, LLC * Sigma-Tau Pharmaceuticals Inc * Sunovion Pharmaceuticals * Takeda Pharmaceuticals North America * Teva Pharmaceuticals * Triax Pharmaceuticals LLC * UCB Pharma Inc * Upsher Smith Laboratories * Vertex Pharmaceuticals Inc * West -Ward Pharms * Zydus Pharmaceuticals USA

For more information on the event, download the brochure.  The Government Programs Summit is taking place March 14-16, 2012, in Baltimore, Maryland. For an exclusive discount of 25% to join us at the event, join the Government Programs LinkedIn Group. If you have any questions, feel free to email Jennifer Pereira.

Tomorrow: Complimentary Web Seminar: The CMS Proposed AMP Rule: What No One is Telling You

The Government Programs Summit Presents The Complimentary Web Seminar:

The CMS Proposed AMP Rule: What No One is Telling You

Presenters: Vincent G. Powell, PPS Group, Ramie Zomisky, PPS Group, Alexis Arroyo, HighPoint Solutions, Andrew Scavone, HighPoint, Solutions,
Time & Date: Thursday, March 1, 2012, 2:00PM - 3:00PM EDT





About the web seminar:
The new AMP Proposed Rule and what it means for you. We will walk through the various proposals within the rule and discuss how those changes, if implemented will impact your calculations, your systems, and your strategies. We will discuss:

• - What are the changes behind the changes that you may not have thought about, but need to
• - How those new changes will impact your calculation methodology
• - What changes will you need to make to your systems

Register to join us today!

Presented by: 

About PPS:
The goal of PPS is to assist our clients with developing and maintaining effective, efficient and compliant operations in support of profitable Managed Markets contracting activities. Towards that end, PPS offers a broad range of services in the Managed Markets Operations and Compliance arena. As a result of our industry experience in the private, public and government healthcare sectors, PPS is well prepared to assist our clients with advisory services, staff augmentation and business process outsourcing.

About HighPoint Solutions:
HighPoint Solutions solves the toughest challenges facing companies in the highly regulated life sciences and healthcare industries by providing clients with practical IT strategies and solution implementations and giving them direct access to the people and technology that get things done. Since 2000, HighPoint’s team of consultants has provided business consulting and technology solutions that continue to deliver business value and competitive advantage to more than 140 clients nationwide.

Medicaid Managed Care Congress Session Spotlight: Health Reform Implementation in a Time of Uncertainty

With the upcoming elections at the end of 2012, many aspects of the Affordable Care Act are on the line.  The Republican presidential candidates want to repeal part or all of the ACA.  Depending on the outcome of the presidential election, healthcare reform is likely to change. This year at the Medicaid Manged Care Congress, we're looking at these possibilities with expert insights from Paul Begala, Political Analyst & Commentator, CNN; Columnist, Newsweek & The Daily Beast. The Medicaid Managed Care Congress will take palce April 30-May 2, 2012, in Baltimore, Maryland. If you'd like to join us, as a reader of this blog when you register and mention code XP1726BLOG, you'll receive a 25% discount off the standard rate.  For more information on this event, download the brochure.

Featured Session: Health Reform Implementation in a Time of Uncertainty
Featured Speaker: Paul Begala, Political Analyst & Commentator, CNN; Columnist, Newsweek & The Daily Beast
About the session: There is a sense of uncertainty in the air, with healthcare being one of the main focuses of the upcoming presidential elections. It’s clear that healthcare reform will still move forward in some way, no matter who the president will be, but it will look very different depending on who is in office.

• • Look into different presidential candidates and their current stances on healthcare
• • Predict the future of Medicaid and the ACA depending on who will be in office

Electronic Healthcare Records moves to Phase 2

Source

Last week, the second stage guidelines were released by the government concerning the move to digital health records.  They can be read here.  According to Kaiser Health News, many of the objectives remain the same - increased usage, engaging patients in their care, and improving transferability between EHRs, but extended.  Companies also have until 2014 to move to Phase 2.  Included is the Summary of Care that must follow patients across referrals and be viewable by the patients online.  This document will be published March 7, then there will be 60 days of commenting.

At the 2012 Medicaid Manged Care Congress, the session "Utilize EHRs for Better Care Coordination" will examine how EHRs can benefit patients as well as look at how patient data can be kept safe with the new electronic format.  For more information on this session and the rest of the agenda, download the brochure here.  Also, as a reader of this blog, when you register to join us today and mention code XP1726BLOG, you'll receive a 25% discount off the standard rate!

For HCPs, there are numerous benefits to EHRs—what are some of the benefits for health plans?

Complimentary Web Seminar: The CMS Proposed AMP Rule: What No One is Telling You

The Government Programs Summit Presents The Complimentary Web Seminar:

The CMS Proposed AMP Rule: What No One is Telling You

Presenters: Vincent G. Powell, PPS Group, Ramie Zomisky, PPS Group, Alexis Arroyo, HighPoint Solutions, Andrew Scavone, HighPoint, Solutions,
Time & Date: Thursday, March 1, 2012, 2:00PM - 3:00PM EDT





About the web seminar:
The new AMP Proposed Rule and what it means for you. We will walk through the various proposals within the rule and discuss how those changes, if implemented will impact your calculations, your systems, and your strategies. We will discuss:

• - What are the changes behind the changes that you may not have thought about, but need to
• - How those new changes will impact your calculation methodology
• - What changes will you need to make to your systems

Register to join us today!

Presented by: 

About PPS:
The goal of PPS is to assist our clients with developing and maintaining effective, efficient and compliant operations in support of profitable Managed Markets contracting activities. Towards that end, PPS offers a broad range of services in the Managed Markets Operations and Compliance arena. As a result of our industry experience in the private, public and government healthcare sectors, PPS is well prepared to assist our clients with advisory services, staff augmentation and business process outsourcing.

About HighPoint Solutions:
HighPoint Solutions solves the toughest challenges facing companies in the highly regulated life sciences and healthcare industries by providing clients with practical IT strategies and solution implementations and giving them direct access to the people and technology that get things done. Since 2000, HighPoint’s team of consultants has provided business consulting and technology solutions that continue to deliver business value and competitive advantage to more than 140 clients nationwide.

More Pharma at Government Programs Than Any Other Event

While the recently released Proposed Rule has the pharmaceutical industry scrambling to begin to strategize how it might need to adapt and change post- Final Rule, the AMP guidance is not the only thing the pharmaceutical industry is talking about.

At the Government Programs Summit, industry professionals will be on hand to discuss not only the AMP Rule, but the 340B pricing program, Medicare Part D, Medicaid Managed Care, Medicare Part B, ASP Pricing and State reimbursement. You will walk away with a thorough knowledge of how various pharmaceutical companies are addressing current challenges and questions with each program to take back and implement at your office.

Session Highlights:
→ Improve the Integrity of the 340B Program
→ Impact on Manufacturer of Multiple Mechanisms for Reimbursement from States
→ Strategies to Overcome the Implementation and Process Challenges of Part D

For more information and these sessions, download the brochure here.

The Government Programs Summit this March 14-16, 2012 in Baltimore, MD!  If you have any questions about the program, please feel free to contact Jennifer Pereira at jpereira@iirusa.com.

MMCC Session Spotlight: Medicaid and Health Insurance Exchange Integration

Questions still abound around Health Insurance Exchanges with some states moving forward with implementation while others waiting on a federal mandate. At this year’s Medicaid Managed Care Congress, hear from our keynote panel of government officials as they discuss how Medicaid relates to Exchanges including different user profiles and health plans need to do now to prepare. The speakers represent states from different stages of Exchange planning and implementation, to provide a 360-degree view of what you should be considering now, regardless of how far along your state is in planning and implementation.  The event will take place April 30-May 2, 2012, in Baltimore, MD.  For more information on the event, download the brochure.  As a reader of this blog, when you register to join us and mention code XP1726BLOG, you'll receive 25% off the standard rate.

John Kaelin,
UnitedHealth Group

Featured Keynote Presentation: Medicaid and Health Insurance Exchange Integration

Distinguished Speaking Panel:
Moderator: John Kaelin, Senior Vice President, Health Reform, UnitedHealth Group
Panelists: Julian J. Harris, MD, MBA, MSc, Medicaid Director, Executive Office of Health and Human Services, Massachusetts, Deborah Florio, Administrator, Center for Child & Family Health, Rhode Island Department of Human Services, Amy Allen, Healthcare Reform Planning Director, Department of Community Health, Michigan

About the session:Health Insurance Exchanges are a huge part of the ACA, and Medicaid’s integration with them varies by states. With a fast approaching 2013 deadline, states are scrambling to create regulations and guidance for plans. With approximately 80% of Exchange participants expecting to receive some sort of subsidy,Medicaid plans need to know how Exchanges will affect their current offerings. In this session, you’ll learn from states that are in various stages of creating Exchanges.

• • Compare and contrast Medicaid enrollees and potential Exchange enrollees
• • Identify how your plan will need to change to better serve additional members

Complimentary Web Seminar: The CMS Proposed AMP Rule: What No One is Telling You

The Government Programs Summit Presents The Complimentary Web Seminar:

The CMS Proposed AMP Rule: What No One is Telling You

Presenters: Vincent G. Powell, PPS Group, Ramie Zomisky, PPS Group, Alexis Arroyo, HighPoint Solutions, Andrew Scavone, HighPoint, Solutions,
Time & Date: Thursday, March 1, 2012, 2:00PM - 3:00PM EDT





About the web seminar:
The new AMP Proposed Rule and what it means for you. We will walk through the various proposals within the rule and discuss how those changes, if implemented will impact your calculations, your systems, and your strategies. We will discuss:

• - What are the changes behind the changes that you may not have thought about, but need to
• - How those new changes will impact your calculation methodology
• - What changes will you need to make to your systems

Register to join us today!

Presented by: 

About PPS:
The goal of PPS is to assist our clients with developing and maintaining effective, efficient and compliant operations in support of profitable Managed Markets contracting activities. Towards that end, PPS offers a broad range of services in the Managed Markets Operations and Compliance arena. As a result of our industry experience in the private, public and government healthcare sectors, PPS is well prepared to assist our clients with advisory services, staff augmentation and business process outsourcing.

About HighPoint Solutions:
HighPoint Solutions solves the toughest challenges facing companies in the highly regulated life sciences and healthcare industries by providing clients with practical IT strategies and solution implementations and giving them direct access to the people and technology that get things done. Since 2000, HighPoint’s team of consultants has provided business consulting and technology solutions that continue to deliver business value and competitive advantage to more than 140 clients nationwide.

Call for Papers: 17th Annual Medicaid Drug Rebate Program Summit

The Institute for International Research is looking for suggested sessions for our upcoming 17th Annual Medicaid Drug Rebate Program Summit, September 10-12, 2012 at the Swissotel in Chicago.

MDRP is the industry-leading event, with more government – led sessions and government attendance, and more pharmaceutical and generic manufacturers than any other event in this space.

We invite you to submit a proposal for a speaking opportunity directly to Heather King, by March 1, 2012. Please send to hking@iirusa.com.

We are currently recruiting pharmaceutical and generic manufacturer executives, state officers, and industry insiders who can share NEW DATA through detailed case studies related to Medicaid Rebate Operations, 340B Regulations, State Contracts and Reporting, and Systems usage.

 Submission Guidelines & Details In your abstract, please provide the following:
 Proposed Title of Session: Objective and purpose
 • A descriptive paragraph of 3-4 sentences describing what is unique or special about the information you plan to share- aka Background Information
• 3-4 bullet points highlighting the strategies, tools and techniques attendees will walk away with- aka Key Takeaways

These are just a few things we cover at MDRP. Please feel free to suggest other timely and relevant topics.

For more information about the MDRP Summit, please visit the website.

We look forward to welcoming you to the event this fall.

A Message from the Medicaid Managed Care Congress Chairperson Vern Smith

Vernon K. Smith, Ph.D. , Managing Principal, HEALTH MANAGEMENT ASSOCIATES, Medicaid Managed Care Congress Chairperson, would like to share this message with you:

All who work in Medicaid and the managed care marketplace have seen major changes in the last few years. But the next few years will see some of the most significant changes in the history of Medicaid, with barely enough time to prepare for them. There are tremendous risks, and also high-stake opportunities in what lies immediately ahead, with major implications for states, Medicaid programs and the managed care plans that serve the expanding numbers of Americans who will be enrolled in the program.

More states are now relying on managed care, and more medically complex populations are being served by Medicaid health plans. The focus has turned to how to improve health care and health outcomes, while finding a way to slow the growth in health care costs, especially for the most vulnerable groups in Medicaid, including the dual eligibles.

The keywords now are innovation, coordination, collaboration, quality improvement and performance. It is an exciting time to be involved with serving the health care needs of this population.

I would like to invite you to attend IIR’s 20th Annual Medicaid Managed Care Congress, taking place on April 30 – May 2 in Baltimore. As you may already know, I have chaired this event for the past few years, and have seen how this even , year after year, has consistently been a place where health plan leaders, and state and federal officials, have come together to share best practices and lessons learned as they seek to make Medicaid better.

Without question, one of my favorite aspects of the Medicaid Managed Care Congress has been the quality of the faculty and the participants. When you download the agenda, you’ll see more than 40 exceptional speakers. There is plenty of opportunity for interaction and informal discussion with the speakers, and many attendees place great value on what they learn from more than 350 fellow participants in the world of Medicaid managed care.

New for 2012:

• - An increased focus on managing care for the dual eligibles
• - Greater state representation than ever before
• - In-depth discussion on health insurance Exchange integration with states from various stages of implementation
• - Tracks especially focused on benefit design excellence, enrollment and retention, and improving clinical outcomes for chronic care management
• - Insight presented by health plan Presidents into building a robust provider networks

Personally, I am very interested in the plenary session focused on the 2012 election, and the implications its outcome will have on Medicaid managed care.

For more information about this conference, visit the website.

As a reader of this blog, when you register today and mention code XP1726BLOG, you’ll receive a discount of 25% off the standard rate. If you have any questions about this program, feel free to contact Jennifer Pereira at jpereira@iirusa.com.

Thank you very much, and I look forward to seeing you this spring in Baltimore!

Sincerely,
Vern

Vernon K. Smith, Ph.D.
Managing Principal, HEALTH MANAGEMENT ASSOCIATES, Medicaid Managed Care Congress Chairperson

AMP Proposed Rule – The Wait is Over

Insights from Katie Lapins, Principal, Government Pricing Specialists:

On Friday, January 27, 2012, CMS issued a Proposed Rule to implement the necessary provisions to the Medicaid Drug Rebate Program (MDRP) as a result of the Affordable Care Act (ACA) and other associated legislation dealing with healthcare reform. The Proposed Rule is on the GP Navigator is here.

IIR's GP Summit is the FIRST conference following the issue of the Proposed Rule and includes more speakers from CMS than any other event. This is the conference to attend to find out what the officials are saying as well as your peers within the industry.

Below are some items of interest after a first reading. As always, please remember that this does not constitute legal or management advice and all manufacturers should consult their own counsel and determine how to handle the items that are relevant to their specific organization, products, etc. It is certainly not comprehensive and will inevitably morph as we all re-read it and share our thoughts and interpretations.

• → It is only a Proposed Rule which means nothing has changed.
• → Pages 1 – 160 include many areas of discussion by CMS regarding their proposed changes; pages 161 – 200 include the actual Proposed Rule.
• → Comments are due April 2, 2012.
• → The definition of “States” and “United States” includes the 50 States, the District of Columbia, Puerto Rico and the U.S. Territories.
• → The ACA listed specific fees that could be treated as “Bona Fide Fees for Service.” CMS has incorporated this language as examples into the criteria originally included under the Deficit Reduction Act (“DRA”).
• → Line Extensions/New Formulations are broadly defined and CMS provides a table (Table 1) detailing those delivery forms that constitute “Oral Solid Dosage Forms.” Both the initial brand name drug and the line extension must be an oral solid dosage form to qualify for the Alternate Rebate/URA.
• → With regards to the AMP calculation, CMS’s guidance is unclear with regards to the “inclusion” or “exclusion” methodology. (Read the discussion on Pages 46 – 49 for the actual, although vague, wording.)
• → Retail community pharmacies are defined to include specialty pharmacies, home infusion centers and home healthcare providers.
• → 5i products will be identified using the FDA’s Routes of Administration (Table 3) and AMP includes sales to those COTs included in non-5i products plus sales to physicians/outpatient facilities, PBMs, mail order, HMOs/MCOs, insurers, hospitals, long-term care providers, hospices and other manufacturers.
• → 5i products will be determined using the VA 90/10 Rule and manufacturers will be required to review this monthly and quarterly.
• → Orphan products voluntarily sold at 340B prices to new covered entities would not be excluded from a manufacturer’s Best Price.
• → As with the DRA, manufacturers will be able to restate Base Date AMP within four quarters of the Final Rule if they have the actual/verifiable data to do so.

We invite you to join the Government Programs Summit this March 7-9, 2012 in Baltimore, MD! Download the brochure here for more information on this year's program and speakers.  If you have any questions about the program, please feel free to contact Jennifer Pereira at jpereira@iirusa.com.

Video: Dr. Lauwrence Baker on Drug Pricing

I came across this video recently while perusing Khan Academy's videos on healthcare and medicine and thought this one discussing how drug prices are set would interest our readers here almost as a primer to the topic but it has some interesting commentary on U.S. drug pricing v. Europe:





Valerie M. Russo is a Senior Social Media Strategist at IIR USA with a technology, anthropology, marketing and publishing business acumen, covering the MDRP Summit beat. She is a published poet and also maintains a literary blog. She may be reached at vrusso@iirusa.com. Follow her @Literanista.

Mark McClellan on the future of the ACA & Healthcare Reform

This week, Marc McClellan was at the Drug Delivery Partnerships Conferncee and shared a few of the insights he had into the future of healthcare with the coming changes of the 2012 Election.  We'd like to share that with you.

Will it Help or Hurt? The Impact of Healthcare Reform on Drug Delivery Innovation, Reimbursement, and Patient Compliance
Mark McClellan, Engelberg Center for Healthcare Reform, Brookings Institute, Centers for Medicare and Medicaid Services

The healthcare world is anxiously awaiting the the decision from the Supreme Court as to whether or not the ACA is legal. McClellan believes that some of the Act will be overturned, but not the whole thing. No matter the individual mandate to buy healthcare insurance will be delayed or repealed entirely. A lot of the other aspects are directly impacted by the 2012 Election. Since it is unpopular, Congress will delay the implementation. McClellan believes that this whole process will take longer and won’t be implemented on schedule in 2014. What won’t change? The insurance market will change, and those with chronic conditions will be covered. Republicans can’t repeal the whole law should they win the 2012 Election. The challenge is how to figure out how to cover more and more people who aren’t covered by insurance.

Rising healthcare costs that are coupled with a lot of rules to restrict spending means it will be very difficult to find a way balance the budget.
 As for FDA Drug Approvals, they are up. This includes more personalized treatments. The process of developing new treatments is very long and uncertain. So success rates are still running around 11-13% for approval. Pharma is moving towards targeting therapies and innovative develop methods require new ways for the FDA to approve them.

Quick approval methods currently from the FDA: Fast track, Priority review, Accelerated approval. There were 8 drugs over the past few years approved this way. It’s hard to set up post approval success measures to get the drugs approved as well.

In the future, McClellan believes that there will be an evidentiary standard (Progressive approval), Targeting , better regulatory guidance and premarket development science

McClellan believes that personalized medicine will have a huge impact on health care in the future, but only if the reimbursement structure is changed from its current structure.

Look who’s Attending the 2012 Medicare Congress

We're less than 3 weeks away from the Medicare Congress in Orlando, February 6-8. We’re expecting a big turnout this year so don’t miss your opportunity to attend the largest, longest running Medicare event in the industry and network with Health Plan executives and CMS officials.

Look at the companies who are attending:
AARP, Aetna, Allergan, American Enterprise Institute, Ameri-Plus Select Services , Arcadian Health Plan & Management Services, Arkansas Blue Cross Blue Shield, BCBS of Minnesota, Bloom Marketing Group, Blue Cross Blue Shield Northern Plains Alliance, Blue Cross Blue Shield of Alabama, Blue Cross Blue Shield of Illinois, Bristol Myers Squibb, Cain Brothers, Capital District Physicians Health Plan, Care N Care Health Plan , CareFirst Blue Cross Blue Shield of Maryland, Cazma LLC, Centers for Medicare & Medicaid Services, CIGNA Healthcare, Colibrium Partners LLC, DMW Worldwide, Dynamic Healthcare Systems Inc, Endo Pharmaceuticals, Epstein Becker Green, Family Physicians Group, First Recovery Group, Forbes, Forest Laboratories, Gorman Health Group LLC, Health Alliance Plan of Michigan, Healthcare Partners, HealthPlanCRM , HealthSpring, HMS Permedion, Humana, Inter Valley Health Plan, Kaiser Family Foundation, Kaiser Permanente, Kaiser Permanente, KBM Group Health Services, LA Care Health Plan, Matrix Medical Network, Milliman USA, National Committee for Quality Assurance, Oliver Wyman Actuarial Consulting, Optum Health, OptumInsight, PharmMD, Preferred Care Partners, Silverlink Communications, Sterling Life Insurance Company, Susquehanna Research Group, SXC Health Solutions Corporation, SXC Health Solutions Corporation, The National Advisory Board on Improving Health Care Services for Seniors, The Weekly Standard, United Community Health Plans, United Health Care, Universal American Corporation, Wellpoint

The Medicare Congress is taking place February 6-8, 2012 in Orlando, Florida. If you’d like to join these companies, use priority code XP1707BLOG to receive 25% off of the standard rate! This is an exclusive discount to this blog. If you have any questions about the agenda or event, please contact Jennifer Pereira.

How Important is Clarification On Current Government Guidance's To Your Organization?

Post Healthcare Reform, not only are Government Programs in a seemingly constant state of flux, but many of the most complicated programs are in a regulatory vacuum period – we know something is coming down the pipe, but have no idea when and how it will affect us.

So what can we do to help? At the Government Programs Summit, we bring together both the key government officials who can offer the most clarity about what to do NOW to prepare for what may come LATER and leading pharmaceutical and generic manufacturer executives who will leave you with practical information on how they are coping with the uncertainty.

In two short days you will:

• - Have unparalleled access to CMS authorities from the Policy, Technical, and Operations Departments, in the session, “CMS AMP Guidance Answers and Next Steps for Medicaid Drug Rebate Program,” as well as the opportunity for one on one, personalized attention in the CMS meeting room.
• - Get an update on 340B guidance directly from HRSA officers, including definitions of “Eligible Patient” under the PHS program in the session, “340B PHS Guidance, Definitions and Oversight Update.”
• - Learn to accrue for the potential 4 million new beneficiaries to Medicare Part D who may fall in to the Donut Hole in 2012 in the session, “Medicare Part D for the Donut Hole: Guidance Updates, Invoicing, Disputes and Appeals Processes.”

Staying up to date on current proposed rules, interpretations, and implementations of government programs is of paramount importance to branded and generic manufactures.

Government Programs and Pricing Compliance Summit will take place March 7-9, 2012, in Baltimore, Maryland. For more information on the program, download the brochure here.

Updates on Duals from Jennifer Coleman of CMS’s Medicare-Medicaid Coordination Office

Your patients with chronic diseases require the greatest investment of money and time for your healthplan. And we know their treatment needs grow more complex if they are dual eligibles. Join us at the 9th annual Medicare Congress - the largest and longest-running conference devoted to the Medicare marketplace – as we have exclusive coverage on the chronically ill and dual eligibles.

Expert speakers include:

• • CMS’s Senior Advisor for the Medicare-Medicaid Coordination Office, Jennifer Coleman, will detail CMS’s new demonstration program to test new financial models for integrating coverage for dual-eligibles. Learn more about their timelines, coverage areas, and best operational practices required to adapt to these new initiatives.
• • Karol Attaway, VP of Operations at HealthCare Services, will detail how you can use risk assessment stratification to predict and prepare for the financial costs of your most seriously ill patients.

To learn more about the program, download the program agenda.

The Medicare Congress is taking place February 6-8, 2012 in Orlando, Florida. If you’d like to join us, use priority code XP1707BLOG to receive 25% off of the standard rate! This is an exclusive discount to this blog. We encourage you to register ASAP because the hotel block is 80% sold out and the negotiated rate expires this Sunday. If you have any questions about the agenda or event, please contact Jennifer Pereira at jpereira@iirusa.com or visit the homepage.